# FDA recall Z-0009-2018

> **Optovue, Inc.** · Class II · device recall initiated 2017-07-27.

## Product

iFusion, Device Listing Number D203271.    Product Usage:  The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and  documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND      iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior  and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic d

## Reason for recall

FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

## Distribution

US Nationwide Distribution in the states of -  AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.

## Key facts

- **Recall number:** Z-0009-2018
- **Recalling firm:** Optovue, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-27
- **Report date:** 2017-09-06
- **Termination date:** 2021-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0009-2018

## Citation

> AI Analytics. FDA recall Z-0009-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0009-2018. Source: US FDA. Licensed CC0.

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